MAUDE Adverse Event Report: COOK IRELAND LTD DUETTE MULTI-BAND MUCOSECTOMY DEVICE; KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

The device was not returned to (b)(4) for evaluation therefore a documentation based investigation was completed.The customers complaint was confirmed on customer testimony.An exact rpn number was not provided and the lot number of the device is unknown therefore a review of the manufacturing and component records could not be completed.A definitive cause for the customers complaint could not be conclusively determined as the actual conditions of device usage could not be replicated, however as stated by the customer a possible root cause of the intramural esophageal hematoma (ieh) could be attributed to "violent retching during endoscopy", the customer also states that this adverse physiological response is uncommon and may occur spontaneously.It is not known if the patients pre-existing condition of "mid-esophageal squamous carcinoma" may have contributed to this event.The instructions for use states the following warning regarding potential complications; " potential complications associated with emr include, but are not limited to: retrosternal pain, nausea, laryngeal laceration, oesophageal perforation, stricture formation, obstruction, haemorrhage." prior to distribution all duette devices are subject to visual inspection to ensure device integrity.These inspections are outlined in internal procedures in place at cook ireland.Based on the information provided and the risk documentation, no corrective actions are warranted.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Intramural esophageal hematoma (ieh) is a rare but well-recognized endoscopic finding, which forms part of the spectrum of esophageal mucosal injuries.It results from disruption of the vasculature within the submucosal plane of the esophageal wall.This leads to dissection of the submucosa by blood, which extends the length of the esophagus and causes intramural expansion and compression of the lumen, resulting in symptoms.The endoscopic appearance is characterized by a distinct, dark bluish mass bulging into the esophageal lumen, which may be localized or diffuse.Although spontaneous ieh is well described, reports of iatrogenic causes are uncommon.Procedure-related causes include violent retching during endoscopy, esophageal biopsy, variceal band ligation, sclerotherapy, and dilatation [we present the first reported case of ieh following esophageal endoscopic mucosal resection (emr).En-bloc emr was performed using a duette multiband mucosectomy device (cook medical, (b)(4)) on a 15-mm paris 0-iia mid-esophageal squamous carcinoma.Initial brisk nonpulsatile bleeding occurred at the resection margin.And was treated using a snare-tip soft-coagulation technique.Hemostasis appeared to be successfully achieved, but a slowly enlarging, dark blue protrusion of the esophageal wall was then observed, consistent with an ieh that was extending craniocaudally from the mucosal defect.Minor oozing was observed from the previous treatment point and was controlled with two hemostatic clips.Although luminal hemostasis had been achieved, the ieh continued to expand, extending distally to involve the lesser curve of the stomach and obliterating the esophageal lumen.After approximately 5 minutes, the hematoma stopped expanding, possibly because of tamponade of the bleeding vessel within the submucosal layer.A computed tomography (ct) scan of the chest was obtained post endoscopy.The patient was managed conservatively with analgesia and clear fluids overnight and was eventually discharged 24 hours later, with no further clinical sequelae on follow-up.Although rare, ieh may occur following emr.Prompt recognition is vital to avoid potentially unnecessary therapeutic interventions.Treatment is usually conservative, with the majority of cases recovering spontaneously.Case report can be viewed here; https://www.Thieme-connect.Com/products/ejournals/html/10.1055/s-0033-1358925.

• Brand Name: DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Type of Device: KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5878026
• MDR Text Key: 52163036
• Report Number: 3001845648-2016-00209
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/16/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention